K Number

Device Name

OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER

Manufacturer

LIGHTLAB IMAGING, INC.

Date Cleared

2014-08-18

(48 days)

Product Code

DQO DOO DQQ

Regulation Number

870.1200

Intended Use

The OPTIS Integrated System with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Integrated System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter. Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Device Description

The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The devices is compatible with Dragonfly OPTIS, Duo, and I imaging catheters, in addition to the PressureWire Aeris. The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the OPTIS Integrated System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K123369

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing techniques to generate OCT images and calculate FFR. There is no mention of AI or ML algorithms being used for image analysis, interpretation, or any other function.

Therapeutic

No.
The device is intended for imaging and physiological parameter determination (FFR) to aid in diagnosis, not to provide therapy itself. The physician uses the information to determine if therapeutic intervention is indicated.

Diagnostic

Yes

The device is intended for "imaging of coronary arteries" and determining "Fractional Flow Reserve (FFR)", which are diagnostic functions. The FFR parameter is used by physicians "to determine if therapeutic intervention is indicated," further indicating a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description explicitly details hardware components like the imaging catheter, fiber-optic technology, and an imaging engine, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system is used for imaging coronary arteries directly within the patient's body and acquiring physiological parameters (FFR) in vivo.
The device utilizes optical coherence tomography (OCT) and pressure measurements. These are imaging and physiological measurement techniques performed in vivo, not laboratory tests on biological samples.

The device is an in vivo diagnostic imaging and physiological measurement system used during interventional procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OPTIS Integrated System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Product codes

DQQ, NOQ

Device Description

The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core.

The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the OPTIS Integrated System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT)

Anatomical Site

coronary arteries

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / catheterization lab

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing included electrical safety testing (IEC 60601-1:2005 + A1: 2012, IEC 60825-1:2nd Ed. 2007, IEC 62366:2007, IEC 60601-1-6:2010, IEC 60601-2-18:2009, 21 CFR 1040.10 sections b5 and b15, IEC 60601-1-2 Ed. 2.1). Software verification and validation were conducted according to FDA regulations, standards, and guidance documents. Design verification and validation were performed on the OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter, including bench testing and pre-clinical animal testing. The results support the device's safety, effectiveness, and substantial equivalence to the ILUMIEN OPTIS predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K123369

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).

Summary

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three heads, symbolizing service to the individual, the family, and the community. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18. 2014

Lightlab Imaging, Inc. % Jeffrey Roberts Principal Regulatory Specialist 4 Robbins Road Westford, MA 01886

Re: K141769

Trade/Device Name: Optis Integrated System, Dragonfly Optis Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO. NOO Dated: June 30, 2014 Received: July 1, 2014

Dear Jeffrey Roberts.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: OPTIS Integrated System

Indications for Use:

The OPTIS Integrated System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter. Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(K) SUMMARY

for the LightLab Imaging, Inc. OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter (per 21CFR 807.92)

1. SUBMITTER/510(K) HOLDER

LightLab Imaging, Inc. 4 Robbins Road Westford, MA 01886

Contact Person:	Jeffrey Roberts
Telephone:	978-577-3451

Date Prepared: 6/30/14

2. DEVICE NAME

Proprietary Name:	OPTIS Integrated System
Common/Usual Name:	Ultrasonic pulsed echo imaging system
Classification Name:	Ultrasonic pulsed echo imaging system
Proprietary Name:	Dragonfly OPTIS Imaging Catheter
Common/Usual Name:	Diagnostic Intravascular Catheter

Diagnostic Intravascular Catheter

3. DEVICE CLASSIFICATION

Classification Name:

The OPTIS Integrated System medical device comprises the following: Classification Name Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1560 Classification Regulation NQQ Product Code

The Dragonfly OPTIS Imaging Catheter device comprises the following: Classification Name: Diagnostic Intravascular Catheter Classification Regulation: 21 CFR 870.1200 Product Code: DQQ

4. PREDICATE DEVICE

. ILUMIEN OPTIS with Dragonfly I Catheter manufactured by LightLab Imaging, Inc. K123369

5. DEVICE DESCRIPTION

6. INTENDED USE

DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

OPTIS Integrated System

The OPTIS Integrated System is equivalent to the ILUMEIN OPTIS predicate device in that both devices perform optical coherence tomography (OCT) and fractional flow reserve (FFR) procedures and provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. Both devices utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine in both devices generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. Both devices are compatible with Dragonfly OPTIS, Duo and I imaging catheters, in addition to the PressureWire Aeris.

The OPTIS Integrated System configuration has been modified from the ILUMIEN OPTIS predicate device to accommodate the integration of the device into a single catheterization lab. The modification includes providing components equivalent to the ILUMIEN OPTIS predicate device and includes 4 additional main hardware components built into the catheterization lab. The 4 additional main hardware components include a System Cabinet, Remoting Cable, DOC Holster and Tableside Controller. This integrated configuration incorporates a control room monitor, keyboard and mouse location and video connection/switching. The engine design has been modified to work with the integration architecture. The software has been upgraded to revision E.1 for the following features:

OPTIS Integrated System Configuration ●
Angio Co-Registration ●

Curtain GUI interface ●
Dragonfly OPTIS Imaging Catheter Support
Continuous calibration for window tube
DICOM modality integration
. Manual pull back triggering
Catheter user connection interface
. Improved acquisition workflow display

Dragonfly OPTIS Imaging Catheter

The Dragonfly OPTIS Imaging Catheter is equivalent to the predicate device in terms of hardware components and operational use. They both are comprised of a catheter body external sheath and internal rotating fiber optic imaging core which emits near infrared light to the tissue and receives reflected light. They both are driven by a stainless steel torque wire by the DOC which is connected to the OCT Imaging system. They are both purged through the central catheter with 100% contrast media prior to use. In both the Dragonfly OPTIS Imaging Catheter and the predate device emitted and returned reflected light are combined and processed by the system software to construct an OCT image.

The Dragonfly OPTIS Imaging Catheter represents an upgrade to the predicate device in terms of performance through the same operational characteristics, and fundamental technological characteristics to include the following:

Multilayer window tube
Flexible proximal end
Improved break away joint
Improved purge tube
. Dual lumen tip
High speed proximal end
155um fiber ●
RFID. ●

8. PERFORMANCE TESTING

The OPTIS Integrated System has been tested and is in compliance with IEC 60601-1:2005 + A1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, • • IEC 60601-1:2005 + A1: 2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60825-1:2nd Ed. 2007 Part 1: Equipment classification and requirements, IEC 62366:2007 Medical devices – Application of usability engineering to medical devices, IEC 60601-1-6:2010 Medical

electrical equipment - Part 1-6: General requirements for basic safety and essential performance, IEC 60601-2-18:2009 Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment. 21 CFR 1040.10 Performance Standards for Light Emitting Products, sections b5 and b15 and IEC 60601-1-2 Ed. 2.1, Electromagnetic emissions and immunity requirements for medical electrical equipment - Group 1 Equipment, Class B for non-life supporting equipment.

In addition to the electrical safety testing performed, software verification and validation was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification and validation was also performed on the OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing and pre-clinical animal testing. The results of this testing concludes the OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device.